510(k) · Cleared
ClearedArchimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simergent, LLC · FKX System, Peritoneal, Automatic Delivery
Cleared on Oct 2, 2025 as substantially equivalent to K002892 (Fresenius Medical Care North America, 2001) and 1 other predicate after a 223-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Oct 2, 2025
- Review
- 223 days
- Class
- Class II
- Product code
- FKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K822549 (1982). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK822549 CCPD Cycler Set W/5 Pronged Safe LockAmerican Medical Products, Inc. · 1982
- This deviceK250523 Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1)…Simergent, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822549 | CCPD Cycler Set W/5 Pronged Safe Lock | American Medical Products, Inc. | 1982 | — |
| 0 (this device) | K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes… | Simergent, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FKX device
- #1 K243371 Byonyks X-1 APD Cycler; Byonyks Automated PD…score 11.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002892 | Frsenius PD Iqcard CyclerSummary page 5…ubmission (No previous submissions) 9. Predicate Device(s): Fresenius PD+ IQCard Cycler and CCPD Cycler Set W/5 Pronged Safe Lock 10. Predicate 510(k) Number: K002892 and K822549 11. Predicate Manufacturer: Fresenius Medical Care Website: https://fmcna.com/… | 2001 |
| * | K822549 | CCPD Cycler Set W/5 Pronged Safe LockSummary page 5…o previous submissions) 9. Predicate Device(s): Fresenius PD+ IQCard Cycler and CCPD Cycler Set W/5 Pronged Safe Lock 10. Predicate 510(k) Number: K002892 and K822549 11. Predicate Manufacturer: Fresenius Medical Care Website: https://fmcna.com/… | 1982 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K002892.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FKX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FKX
209in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FKX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKX
3,128in 2025
MAUDE reports naming product code FKX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 147 |
| 2008 | 0 | — | 0 | 702 |
| 2009 | 0 | — | 0 | 340 |
| 2010 | 0 | — | 5 | 4,966 |
| 2011 | 2 | — | 2 | 11,304 |
| 2012 | 0 | — | 2 | 18,034 |
| 2013 | 2 | — | 1 | 22,093 |
| 2014 | 1 | — | 4 | 28,289 |
| 2015 | 1 | — | 2 | 24,663 |
| 2016 | 0 | — | 1 | 6,137 |
| 2017 | 1 | — | 0 | 3,127 |
| 2018 | 2 | — | 3 | 5,927 |
| 2019 | 0 | — | 0 | 5,972 |
| 2020 | 1 | — | 1 | 4,598 |
| 2021 | 0 | — | 0 | 5,076 |
| 2022 | 4 | 209 | 0 | 4,503 |
| 2023 | 0 | — | 2 | 3,913 |
| 2024 | 0 | — | 0 | 3,771 |
| 2025 | 2 | — | 1 | 3,128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Archimedes APD system is an Automated Peritoneal Dialysis system indicated for acute and chronic peritoneal dialysis for adult patients in clinical and home use. A care partner is not required. The following therapies are supported: Continuous Cyclic Peritoneal Dialysis (CCPD) and Intermittent Peritoneal Dialysis (IPD). Mid-day exchanges are not supported.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250523 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250523: Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250523
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026